Medical Devices and IVDsFit for the new EU-Regulations: Your complete seminar for projekt, study and job. E-book. Formato EPUB Wolfgang Ecker   -  Books On Demand, 2022  - 

With this book, you get a really complete seminar for the new Regulations on medical devices and IVDs in the EU, ready at hand, at any time.These EU regulations create new rules for medical technology and laboratory diagnostics in Europe. Concise regulatory know-how is now required to keep or reposition medical devices and in vitro diagnostics on the European market, from syringes, contact lenses, medical device apps, pregnancy tests, nuclear magnetic resonance tomography to cancer tests, genetic diagnostics, HIV tests, hip implants, heart catheters, artificial spinal discs, stents and pacemakers. Concise regulatory training and further education of employees in companies and health care facilities is the order of the day. This also applies to biomedical and medical technology students at universities of applied sciences and biomedical universities, start-ups and spin-offs, who must make use of this know-how from the initial product idea through the further stages of product development to market access.The book provides a thorough, compact course on the new regulations, starting with perfect overview and easy navigation and going into depth where you need it: this book will make you fit and confident for the new European challenges!344 pages; 47 col. figures; 26 tables

Clinical Evaluation and Investigation of Medical Devices under the new EU-Regulation. E-book. Formato EPUB Wolfgang Ecker   -  Books On Demand, 2020  - 

"The concept of clinical evaluation and the framework for clinical investigations have been significantly enforced within the new EU-Medical Device Regulation (MDR). This book provides in-depth and practice-oriented guidance on the systematic identification and generation of clinical data through clinical investigations and other relevant sources. It addresses the needs of all stakeholders, be it manufacturers, notified bodies or competent authorities, when they have to plan, perform or assess clinical evaluations and investigations for medical devices on the way to conformity assessment and CE marking.It is a valuable tool of qualification for clinicians and related experts when preparing for a role of a clinical evaluator in the field, either when serving any of the stakeholders or when trying to make their own involvement stand out in start-ups, spin-offs or other development projects or in counselling services." Dr. Tom Melvin, Co-Chair, Clinical Investigation and Evaluation Working Group